Motor Neuron Disease, Amyotrophic Lateral SclerosisOptNIVentNCT05299372
Telemonitoring in NIV MND (OptNIVent)
A study testing Telemonitoring via Careportal® in people with Motor Neuron Disease, Amyotrophic Lateral Sclerosis, run by Liverpool University Hospitals NHS Foundation Trust.
Trial summary
This is a feasibility study of telemonitoring system for people with MND/ALS, who are on NIV, via a call centre operated by a local clinical commissioning group. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Motor Neuron Disease, Amyotrophic Lateral Sclerosis
- What is being tested?
- Telemonitoring via Careportal®
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- No sites listed yet
- Study dates
- 25 Apr 2022to 31 Dec 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Confirmed diagnosis of MND with respiratory muscle weakness
- Adults who are capable of informed consent
- Patients for whom we anticipate survival of 6 months or more
- Able to communicate with an interviewer. Alternative communication methods will be used as required in order to mitigate communication difficulties.
Who cannot join
- Patients who have declined NIV
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Optimising the Management of Ventilated Patients and Quality of Life in Motor Neurone Disease: a Pilot Study
This is a feasibility study of telemonitoring system for people with MND/ALS, who are on NIV, via a call centre operated by a local clinical commissioning group.
Read the detailed description
This study will test the feasibility of previously developed Telehealth system, using a device called Careportal®, to monitor people with MND/ALS who are using non-invasive ventilation (NIV). The Careportal® is a CE marked portable tablet computer device allowing telecommunication between patients and their care team through bespoke question sets, overnight oximetry test, and patient-ventilator interaction(PVI) data. Previously, the weekly telemonitoring via Careportal® was found to be an effective method to monitor symptom changes, allowing clinicians to optimise the care of ventilated patients with MND. This study will assess the practicality of using Careportal® in the care of ventilated patients with MND by monitoring patients through a patient support call centre. The call centre will screen the data and liaise with appropriate clinicians regarding changes of symptoms.
- Being tested
- Telemonitoring via Careportal®
- Keywords
- non-invasive ventilation, Telehealth, Telemonitoring
- Medical subject headings
- Amyotrophic Lateral Sclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Telemonitoring via Careportal®Other
The question sets and overnight oximetry results will be monitored and screened by a call centre commissioned by the Liverpool Clinical Commissioning Group (LCCG). The call centre will screen the weekly data and contact clinicians where appropriate (i.e. NIV team, MND specialist nurse, or patient's GP). PVI data will be examined by NIV physiotherapists, where required, following the contact from LCCG to ensure the maximum benefits of NIV to patients.
| Study group | Role | What they receive |
|---|---|---|
| Telemonitoring via Careportal® | Other | Participants will be prompted by the device to answer two sets of questions every week: 10 items (1 nested) in the morning and 16 items (4 nested) in the evening. Also on a weekly basis, patients will be prompted to perform overnight oximetry test, and upload patient-ventilator interaction data (PVI) via Careportal®. Receives: Other: Telemonitoring via Careportal® |
What is being measured
The primary outcome is the main question the study is designed to answer.
Acceptability - Qualitative data through semi-structured interviews and focus groups
Qualitative data will be collected through focus groups with participants, their lay caregivers, and clinicians. Separate focus groups will be conducted for the three participant groups with an option of individual interviews for patients and lay caregivers.
Measured: Qualitative data will be conducted at 3-month
Usability - Qualitative data through semi-structured interviews and focus groups
Qualitative data will be collected through focus groups with participants, their lay caregivers, and clinicians. Separate focus groups will be conducted for the three participant groups with an option of individual interviews for patients and lay caregivers.
Measured: Qualitative data will be conducted at 3-month
Secondary outcomes (11)
Patient Reported Outcome Measurement - Neurological Fatigue Index for MND
13-item questionnaire assessing fatigue experienced by people with motor neurone disease. The questionnaire consists of two sub-scales: Weakness sub-scale and Energy sub-scale. Eight items make up the Summary Fatigue scale with the total scores range from 0 to 24. Higher scores indicate higher levels of fatigue
Measured: Baseline and then 6-weekly up to 24 weeks
Patient Reported Outcome Measurement - Epworth Sleepiness Scale
8-item questionnaire to measure general levels of sleepiness. Total scores range from 0 to 24. Higher scores indicate higher levels of sleepiness.
Measured: Baseline and then 6-weekly up to 24 weeks
Patient Reported Outcome Measurement - Dyspnoea-12
12-item questionnaire to measure overall breathlessness severity. Total scores range from 0 to 36. Higher scores indicate higher breathless severity.
Measured: Baseline and then 6-weekly up to 24 weeks
Patient Reported Outcome Measurement - revised Amyotrophic Lateral Sclerosis Functional Rating Scale
12-item questionnaire to monitor the disease progression covering bulbar, motor and respiratory function. Total scores range from 0 to 48. Higher scores indicate better function.
Measured: Baseline and at 3-month and 6-month
Patient Reported Outcome Measurement - Hospital Anxiety and Depression Scale
14-item questionnaire to measure anxiety and depression levels. The questionnaire consists of anxiety sub-scale and depression sub-scale. Scores for each sub-scale range from 0 to 21. Higher scores indicate greater anxiety/depression levels.
Measured: Baseline and at 3-month and 6-month
Patient Reported Outcome Measurement - the World Health Organization Quality of Life Scale-BREF
26-item questionnaire consists of Physical Health domain, Psychological domain, Social relationships domain, and Environment domain in addition to Overall QoL (1-item) and General Health (1-item) facets. Total scores range from 0 to 100. Higher scores indicate indicate higher quality of life.
Measured: Baseline and at 3-month and 6-month
Patient Reported Outcome Measurement - 5-level EQ-5D
The questionnaire consists of 5-item to measure health based on five domains: Mobility, Self-care, Usual Activities, Pain/Discomfort, and Anxiety/Depression. Each domain has 5 levels indicating worsening health, from having no problems to having severe problems. The questionnaire also contain one visual analogue scale measuring health-reported health: 0 indicates worst health while 100 indicates the best health.
Measured: Baseline and at 3-month and 6-month
Patient Reported Outcome Measurement - General Satisfaction
6-item General Satisfaction sub-scale from Patient Satisfaction Questionnaire. Total scores range from 6 to 30. Higher scores indicate greater satisfaction.
Measured: Baseline and at 3-month and 6-month
Patient Reported Outcome Measurement - Access, Availability and Convenience
12-item Access, Availability and Convenience sub-scale from Patient Satisfaction Questionnaire. Total scores range from 12 to 60. Higher scores indicate greater access, availability and convenience.
Measured: Baseline and at 3-month and 6-month
Self-Reported Outcome Measurement - Caregiving Distress Scale
17-item questionnaire to measure caregiver distress, covering five dimensions: Relationship distress, Emotional burden, Social impact, Care-receiver demands, and Personal cost. Total scores range from 0 to 68. Higher scores indicate greater distress.
Measured: Baseline and at 3-month and 6-month
Service evaluation
Patient Level Information and Costing System (PLICS)
Measured: At the end of study i.e. at 6-month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Mar 2022
- Study start25 Apr 2022 (estimated)
- Primary completion31 Oct 2022 (estimated)
- Study completion31 Dec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Motor Neuron Disease, Amyotrophic Lateral SclerosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 15 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Liverpool University Hospitals NHS Foundation Trust
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Robert M Angus, MRCP, FRCP, Principal investigator, Liverpool University Hospitals NHS Foundation Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05299372
- Sponsor's protocol ID
- 767/14
- Acronym
- OptNIVent
- Status last verified
- Mar 2022
- First submitted
- 21 Sep 2021
- Last updated
- 29 Mar 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Ando H, Ashcroft-Kelso H, Halhead R, Young CA, Chakrabarti B, Levene P, Cousins R, Angus RM. Incorporating self-reported questions for telemonitoring to optimize care of patients with MND on noninvasive ventilation (MND OptNIVent). Amyotroph Lateral Scler Frontotemporal Degener. 2019 Aug;20(5-6):336-347. doi: 10.1080/21678421.2019.1587630. Epub 2019 Mar 26.
PubMed 30912468
Study at a glance
From the registry record, last updated by the sponsor on 29 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Optimising the Management of Ventilated Patients and Quality of Life in Motor Neurone Disease: a Pilot Study
- ClinicalTrials.gov ID
- NCT05299372
- Acronym / sponsor ID
- OptNIVent / 767/14
- Keywords
- non-invasive ventilation, Telehealth, Telemonitoring
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 15 participants (estimated)
- Lead sponsor
- Liverpool University Hospitals NHS Foundation TrustOther government
- Study start
- 25 Apr 2022 (estimated)
- Primary completion
- 31 Oct 2022 (estimated)
- Study completion
- 31 Dec 2022 (estimated)
- First posted
- 29 Mar 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a feasibility study of telemonitoring system for people with MND/ALS, who are on NIV, via a call centre operated by a local clinical commissioning group.
Detailed description
This study will test the feasibility of previously developed Telehealth system, using a device called Careportal®, to monitor people with MND/ALS who are using non-invasive ventilation (NIV). The Careportal® is a CE marked portable tablet computer device allowing telecommunication between patients and their care team through bespoke question sets, overnight oximetry test, and patient-ventilator interaction(PVI) data. Previously, the weekly telemonitoring via Careportal® was found to be an effective method to monitor symptom changes, allowing clinicians to optimise the care of ventilated patients with MND. This study will assess the practicality of using Careportal® in the care of ventilated patients with MND by monitoring patients through a patient support call centre. The call centre will screen the data and liaise with appropriate clinicians regarding changes of symptoms.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Telemonitoring via Careportal® | Other | Other: Telemonitoring via Careportal®Participants will be prompted by the device to answer two sets of questions every week: 10 items (1 nested) in the morning and 16 items (4 nested) in the evening. Also on a weekly basis, patients will be prompted to perform overnight oximetry test, and upload patient-ventilator interaction data (PVI) via Careportal®. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Confirmed diagnosis of MND with respiratory muscle weakness
- Adults who are capable of informed consent
- Patients for whom we anticipate survival of 6 months or more
- Able to communicate with an interviewer. Alternative communication methods will be used as required in order to mitigate communication difficulties.
Key exclusion criteria (1 listed)
- Patients who have declined NIV
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Telemonitoring via Careportal®The question sets and overnight oximetry results will be monitored and screened by a call centre commissioned by the Liverpool Clinical Commissioning Group (LCCG). The call centre will screen the weekly data and contact clinicians where appropriate (i.e. NIV team, MND specialist nurse, or patient's GP). PVI data will be examined by NIV physiotherapists, where required, following the contact from LCCG to ensure the maximum benefits of NIV to patients. | Other | Telemonitoring via Careportal® |
Primary outcome
Acceptability - Qualitative data through semi-structured interviews and focus groups
Time frame: Qualitative data will be conducted at 3-month
Qualitative data will be collected through focus groups with participants, their lay caregivers, and clinicians. Separate focus groups will be conducted for the three participant groups with an option of individual interviews for patients and lay caregivers.
Usability - Qualitative data through semi-structured interviews and focus groups
Time frame: Qualitative data will be conducted at 3-month
Qualitative data will be collected through focus groups with participants, their lay caregivers, and clinicians. Separate focus groups will be conducted for the three participant groups with an option of individual interviews for patients and lay caregivers.
11 secondary outcomes
Patient Reported Outcome Measurement - Neurological Fatigue Index for MND
Time frame: Baseline and then 6-weekly up to 24 weeks
Patient Reported Outcome Measurement - Epworth Sleepiness Scale
Time frame: Baseline and then 6-weekly up to 24 weeks
Patient Reported Outcome Measurement - Dyspnoea-12
Time frame: Baseline and then 6-weekly up to 24 weeks
Patient Reported Outcome Measurement - revised Amyotrophic Lateral Sclerosis Functional Rating Scale
Time frame: Baseline and at 3-month and 6-month
Patient Reported Outcome Measurement - Hospital Anxiety and Depression Scale
Time frame: Baseline and at 3-month and 6-month
Patient Reported Outcome Measurement - the World Health Organization Quality of Life Scale-BREF
Time frame: Baseline and at 3-month and 6-month
Patient Reported Outcome Measurement - 5-level EQ-5D
Time frame: Baseline and at 3-month and 6-month
Patient Reported Outcome Measurement - General Satisfaction
Time frame: Baseline and at 3-month and 6-month
Patient Reported Outcome Measurement - Access, Availability and Convenience
Time frame: Baseline and at 3-month and 6-month
Self-Reported Outcome Measurement - Caregiving Distress Scale
Time frame: Baseline and at 3-month and 6-month
Service evaluation
Time frame: At the end of study i.e. at 6-month
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Mar 2022.
- Background: PubMed 30912468Ando H, Ashcroft-Kelso H, Halhead R, Young CA, Chakrabarti B, Levene P, Cousins R, Angus RM. Incorporating self-reported questions for telemonitoring to optimize care of patients with MND on noninvasive ventilation (MND OptNIVent). Amyotroph Lateral Scler Frontotemporal Degener. 2019 Aug;20(5-6):336-347. doi: 10.1080/21678421.2019.1587630. Epub 2019 Mar 26.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Robert M Angus, MRCP, FRCP principal investigator
Liverpool University Hospitals NHS Foundation Trust
Questions about this trial
What is this clinical trial studying?
A study testing Telemonitoring via Careportal® in people with Motor Neuron Disease, Amyotrophic Lateral Sclerosis, run by Liverpool University Hospitals NHS Foundation Trust.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 29 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Hikari Ando, PhD (0151529, hikari.ando@nhs.net), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Acceptability - Qualitative data through semi-structured interviews and focus groups (time frame: Qualitative data will be conducted at 3-month). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05299372, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Mar 2022.